NCT04833517

Prospective REgistry of Targeted RadionucLide TherapY in Patients With mCRPC (REALITY Study)

REALITY Study: Analysis of a Prospective REgistry to Assess Outcome and Toxicity of Targeted RadionucLide TherapY in Patients With mCRPC in Clinical Routine.

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Universität des Saarlandes · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This prospective registry aims to assess outcome and toxicity of targeted radionuclide therapies in patients with advanced prostate cancer in clinical routine. While the major investigated treatment modality is prostate-specific membrane antigen (PSMA)-targeted radioligand therapy, also other radionuclide therapies such as Ra223 and liver-directed radioembolization are included. The investigators believe that prospectively assessed long-term outcome data on implementation of radionuclide therapy, especially in the palliative setting of advanced mCRPC, help to better define the real benefits and risks of the respective treatment modalities for patients regarding survival and quality-of-life.

Detailed description

Targeted radionuclide therapy is comprised of different modalities that may be applied in advanced prostate cancer, either targeting bone metastases (mainly using Radium-223), any site of metastases with PSMA-expression (ß- / alpha-emitter labelled radioligands) or loco-regionally applying internal radiation (Yttrium-90 microspheres) to metastatic liver disease. While in Germany, each form of treatment is used in clinical routine, data is sparse regarding the real benefits and risks of respective modalities, also when used in a sequential order. As an example, patients receiving Ra223 treatment may later undergo PSMA targeted radioligand therapy, with little data available on dependent response relationships or cumulative risks. Prospective assessment of outcomes and toxicities in a radionuclide therapy registry is apparently superior over retrospective analyses of selected patient populations. The goal of the REALITY study is to gain a better understanding of the real-life clinical application of radionuclide therapies, with a focus on PSMA-targeted radioligand therapy in a high-volume treatment centre, and the impact of each treatment for patient outcome. Based on primary and secondary outcome measures the potential prediction of treatment benefit by baseline patient and tumor characteristics, and early changes of biomarkers will be of interest.

Conditions

• Prostate Cancer Metastatic
• Castration Resistant Prostatic Cancer
• Advanced Prostate Carcinoma

Timeline

• Start date: 2016-01-01
• Primary completion: 2024-12-31
• Completion: 2025-12-31
• First posted: 2021-04-06
• Last updated: 2022-12-08

Locations

1 site across 1 country: Germany